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Received: 16 January 2018 Revised: 12 July 2018 Accepted: 20 July 2018 DOI: 10.1111/hex.12826
ORIG INAL RESE ARCH PAPER
Interventions to support shared decision making for hypertension: A systematic review of controlled studies Rachel A. Johnson BM Bch MRes1
| Alyson Huntley PhD1 |
Rachael A. Hughes PhD2 | Helen Cramer PhD1 | Katrina M. Turner PhD1 | Ben Perkins MBBS, BSc1 | Gene Feder MD, FRCGP1 1
Centre for Academic Primary Care, Bristol Medical School, Bristol, UK
2 Population Health Sciences, Bristol Medical School, Bristol, UK
Correspondence: Rachel A. Johnson, BM Bch MRes, Centre for Academic Primary Care, Bristol Medical School, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK (
[email protected]). Present address Ben Perkins, Conquest Hospital, Hastings, UK. Funding information Rachel Johnson is funded by a National Institute for Health Research doctoral fellowship (UK, Reference DRF-2013- 06-034). Rachael Hughes’ salary is supported by the Wellcome Trust Institutional Strategic Support Fund and the Elizabeth Blackwell Institute.
Abstract Background: Hypertension (high blood pressure) is a common long-term health condition. Patient involvement in treating and monitoring hypertension is essential. Control of hypertension improves population cardiovascular outcomes. However, for an individual, potential benefits and harms of treatment are finely balanced. Shared decision making has the potential to align decisions with the preferences and values of patients. Objective: Determine the effectiveness of interventions to support shared decision making in hypertension. Search strategy: Searches in MEDLINE, EMBASE, CINAHL, Web of Science and PsycINFO up to 30 September 2017. Eligibility criteria: Controlled studies evaluating the effects of shared decision- making interventions for adults with hypertension compared with any comparator in any setting and reporting any outcome measures. Results: Six studies (five randomized controlled trials) in European primary care were included. Main intervention components were as follows: training for health-care professionals, decision aids, patient coaching and a patient leaflet. Four studies, none at low risk of bias, reported a measure of shared decision making; the intervention increased shared decision making in one study. Four studies reported blood pressure between 6 months and 3 years after the intervention; there was no difference in blood pressure between intervention and control groups in any study. Lack of comparability between studies prevented meta-analysis. Conclusions: Despite widespread calls for shared decision making to be embedded in health care, there is little evidence to inform shared decision making for hypertension, one of the most common conditions managed in primary care. KEYWORDS
hypertension, patient participation, primary health care, shared decision making, systematic review
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2018 The Authors Health Expectations published by John Wiley & Sons Ltd Health Expectations. 2018;1–17.
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1 | BAC KG RO U N D
will vary with an individual’s overall cardiovascular risk, and potential disbenefits include medication side-effects and the bur-
Shared decision making is a process by which clinicians and pa-
den of having to take daily medication. Patients making decisions
tients work together to make health-care choices, based on clinical
about antihypertensive drug treatment require discussions about
evidence and the patient’s informed preferences.1 Shared decision
treatment to be personalized in order for the decisions to make
making is viewed as an ethical imperative by health-care profes-
sense to them. 21 Shared decision making for hypertension has the
2
sional regulatory bodies and is embedded in health policy in several
potential to address this challenge, yet it is unclear how best to
countries, including the UK and the United States.3,4 It is increasingly
support shared decision making for hypertension, and the effect
advocated in the care of all conditions, including chronic health-care
of shared decision making on outcomes is unknown. Given the
5
conditions such as hypertension (high blood pressure) Implementing
high prevalence of hypertension and its impact on cardiovascular
shared decision making in routine care has proven challenging, and
risk, shared decision making for hypertension may have profound
many barriers have been identified from both patient and health-
impacts at both individual and public health levels.
care professional perspectives.6,7 Interventions to support shared decision making include those which prepare health-care teams, individual clinicians or patients be-
1.1 | Objective
fore consultations (e.g patient coaching interventions, decision aids,
The main objective of this study was to determine the effective-
clinician or health-care team training interventions), and those which
ness of interventions, including but not limited to decision aids, to
help practitioners and patients make decisions together during con-
support shared decision making in hypertension. A second objec-
sultations, notably decision aids. There is evidence from conditions
tive was to describe the outcomes that have been used to evaluate
other than hypertension that shared decision making can lead to
interventions supporting shared decision making for hypertension.
more appropriate care,8 reduce overtreatment,9 improve health outcomes10 and may reduce health-care treatment costs.11 A systematic review of interventions to support the adoption of shared decision 12
making by health professionals
2 | M E TH O DS
was unable to draw conclusions
about the most effective interventions for supporting health pro-
The protocol for this systematic review was registered on PROSPERO
fessionals’ adoption of shared decision making, due to the paucity of
(CRD42015014143). 22
evidence. None of the studies in that review focused on people with hypertension. A recent systematic review of randomized controlled trials, including one study that did focus on hypertension manage-
2.1 | Search strategy
ment, found that people exposed to decision aids feel more knowl-
We used search strategies incorporating subject heading and text
edgeable, clearer about their values and may make choices more in
word searches focused on shared decision making and hypertension
line with their values.8
(see Appendix 1 for MEDLINE searches). The search was developed
Hypertension affected 31% of the world’s adult population in
in MEDLINE and adapted for subsequent databases. We searched
201013; it increases the risk of cardiovascular conditions such as
MEDLINE, EMBASE, CINAHL, Web of Science, PsycINFO and the
strokes and heart attacks and is the leading preventable cause of
Cochrane library from their inception to September 2017. We iden-
premature death worldwide.14 Observational studies show a pro-
tified further potentially relevant articles from forward (via Google
gressive rise in cardiovascular risk as systolic blood pressure rises
Scholar) and backward (reference list of paper) citation tracking of
15
above 115 mmHg.
Hypertension is diagnosed when a person’s
included studies, applying the same inclusion criteria.
blood pressure (BP) exceeds a threshold, typically 140/90 mmHg.16 Management is characterized by monitoring of blood pressure alongside other cardiovascular risk factors and the use of lifestyle
2.2 | Eligibility criteria
measures, usually combined with antihypertensive drug treatment
Following Cochrane Effective Practice and Organisation of Care
to reduce blood pressure below treatment thresholds. Optimal
(EPOC) guidance, 23 we included randomized controlled trials (RCTs),
17
treatment targets vary and are the subject of vigorous debate.
nonrandomized controlled trials, controlled before-after studies
Treatment is typically lifelong with adjustment and, often, inten-
and interrupted time series studies. We included published studies
sification of antihypertensive treatment over time. Hypertension
reporting on interventions supporting shared decision making for
control is frequently considered suboptimal, that is it fails to reach
adults (>18) with hypertension. Eligible comparator interventions
specified treatment targets.18
were control or any other interventions. Interventions could be deliv-
Achieving blood pressure control has the potential for im-
ered in any health-care setting, either before or during consultations
19,20
proved outcomes and cost savings at the population level.
with any health-care professionals. We included studies describing
However, from an individual patient’s perspective, the potential
interventions that supported shared decision making by support-
benefits are less certain. Options to reduce blood pressure include
ing one of the two following processes of shared decision making:
a choice of medications and lifestyle changes. Potential benefit
supporting a patient’s consideration of their options in relation to
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JOHNSON et al.
a health-care choice; or supporting a patient to consider their val-
(SMDs). Meta-analysis was planned if there were at least three stud-
ues and preferences in relation to a health-care choice. We included
ies with comparable interventions and outcomes at low risk of bias.
studies in which only a proportion of participants were hyperten-
If meta-analysis was appropriate, we planned to assess heterogene-
sive, if study outcomes were reported separately for the hyperten-
ity amongst studies using the I2 statistic. Analyses were carried out
sive group. We excluded studies reporting interventions unrelated to
using Stata version 14.1. 24
health-care decisions, for example, purely educational interventions
As meta-analysis did not prove possible, we present a narrative
that aimed to increase hypertension knowledge without reference to
synthesis of the studies. 25 The included studies are summarized in
health-care choices faced by the patient. We excluded interventions
the text, in a table of study characteristics and in a risk of bias sum-
that aimed to increase the involvement of patients in their own care
mary table. The outcomes reported by included studies, grouped by
generally, but not in health-care decisions specifically. To develop an
type of intervention, are reported in Figure 3. Outcomes reported
understanding of how interventions to support shared decision mak-
by at least three of the included studies are compared across the
ing were evaluated, we included studies regardless of the outcomes
studies in forest plots and in the text.
assessed. No date or language restrictions were applied.
2.3 | Reference management and study selection
3 | R E S U LT S
EndNote X7.7 and Access 2013 were used to manage the references.
Searches were run in December 2014 and updated in September
Duplicates were removed from the EndNote file. Titles and abstracts,
2017. A total of 6424 unique articles were screened, of which 91
and subsequently full texts, were screened independently by two re-
full-text articles were assessed, and 11 reports of 6 studies were
viewers (RJ, BP or AH); disagreements were resolved by discussion
included in the review (Figure 1). 26-34
with reference to a third reviewer where necessary (KT, GF and HC). If there was insufficient detail on potentially relevant studies within the report abstract, it was screened as full text. Reasons for exclusions of full-text reports were documented.
3.1 | Included studies Eleven papers were published from six studies, all based in primary
We scrutinized the text and reference lists of relevant systematic
care (Table 1). Five studies reported randomized controlled tri-
reviews for potentially eligible studies. Conference abstracts and
als, 26,27,29,30 of which two were cluster randomized. 29,30 The remain-
relevant study protocols were followed up either by contact with
ing study was a nonrandomized controlled study. 28
the author where possible or by searching for subsequent publications in PubMed.
3.2 | Profile of patients The range of mean age of study participants was 58.5-6 4.5 years,
2.4 | Data extraction and risk of bias
and the range of female participants was 32.5%-66.0%. In five stud-
Data were extracted into a custom-designed table which had been
ies, all recruited patients had hypertension. 26-29,34 In the remaining
previously piloted by one reviewer (RJ). All data were extracted by
study,30 only a proportion of participants were hypertensive, al-
one reviewer and checked by a second. Data were extracted on study
though all had raised cardiovascular risk. Only results relating to the
type, setting, participants, interventions, controls, type of decision
hypertensive patients within this study are included in this review.30
supported and outcome measures. Our prespecified primary outcome was any measure of shared decision making. Consistent with our objective of documenting what outcomes have been used to evaluate
3.3 | Profile of interventions
interventions to support shared decision making, all other reported
The interventions were heterogeneous in their content and often
outcomes were extracted as secondary outcomes. We extracted esti-
multicomponent (Table 1). Intervention components included
mated effect sizes with 95% confidence intervals for each outcome as-
training interventions for clinicians, 28,29,34 coaching for patients,
sessed, using odds ratios for binary variables and mean differences for
decision aids and written materials for patients. 26,34 Tinsel and
continuous variables. Risk of bias was assessed independently by two
colleagues29,32 evaluated a shared decision-making training pro-
23
reviewers using the Cochrane EPOC risk of bias tool ; disagreements
gramme for general practitioners, to understand whether it
were resolved by discussion. Risk of bias in some domains varied with
increased patients’ perceived participation, optimized blood pres-
the type of outcome measure; risk of bias grouped by type of outcome
sure values, enhanced patient knowledge of hypertension and im-
is presented in Figure 2.
proved adherence. Deinzer and colleagues28,35 evaluated a shared decision-making training intervention for general practitioners, 28
2.5 | Data synthesis
testing the hypothesis that shared decision making would lead to more effective lowering of hypertension. In the study by Cooper
For data pooling, where outcomes were assessed using different
and colleagues, 34,36 a communication skill training intervention for
measures, we planned to calculate standardized mean differences
physicians and a coaching intervention for patients were evaluated,
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JOHNSON et al.
Identification
4
7813
14
Records identified through database searching
Records identified through author contact and reference lists
7827
Screening
Screened for duplicates
1403
Duplicates removed
6424
Records after duplicates removed that were screened by title and abstract
6333
Records excluded
Included
Eligibility
80
91
Full-text articles assessed for eligibility
Full-text articles excluded, with reasons: Not shared decision making (35) Not controlled study (11) Not hypertensives (2) Hypertensives not separated out (10) No relevant outcomes reported (22)
11 reports of 6 studies included in synthesis
F I G U R E 1 PRISMA flow diagram
separately and in combination with each other, for their impact on
aimed to support shared decision making in consultations where
patient-physician communication and care processes, patient ad-
multiple treatment options to lower cardiovascular risk were being
herence to medication and lifestyle recommendations, and blood
considered, including decisions about commencing antihyperten-
pressure control. In two studies, the main intervention compo-
sive therapy. 30
nent was a decision aid. 27,30 In the first of these, Denig and colleagues 30,33 set out to support interactions between patients and health-c are providers using a decision aid focusing on shared goal
3.4 | Risk of bias
setting and decision making for patients with diabetes considering
Risk of bias assessment is reported in Figures 2 and 3. One nonrand-
their treatment options, including for management of hyperten-
omized controlled study was included in the review and was at high
sion. In the second study, Montgomery and colleagues27,31 set out
risk of bias for most domains. Two of the RCTs were at uncertain or
to evaluate the effect of decision analysis as an aid to patient deci-
high risk of bias for the majority of domains. 26,34 Three RCTs were at
sion making for newly diagnosed hypertension on decision quality,
low risk for most domains. 27,29,30 However, the two RCTs reporting
treatment choices, clinical outcomes, and treatment and consult-
shared decision making were at uncertain risk of bias for this out-
ing behaviour.
31
In the final study,
26
the intervention was a leaflet
distributed to patients with hypertension and hypothesized to lead
come because of the impossibility of blinding for, as well as the subjectivity of, this outcome.
to greater involvement of patients in their health-c are choices, with the potential for improving on blood pressure control. In four studies, 26,28,29,34 interventions supported the involve-
3.5 | Outcomes
ment of patients with established hypertension, without specify-
The included studies assessed a range of outcome measures.
ing which treatment choices were being supported. In one study, 27
Outcomes reported, by intervention type and risk of bias, are
the decision supported was whether to commence antihyperten-
shown in Figure 3. Four studies reported a measure of shared
sives in newly diagnosed hypertensive patients. The intervention
decision making. 27,28,32,34 Clinical outcomes reported were
was an approximately hour-long session of decision analysis which
as follows: blood pressure (five studies), 26,28,29,31,34 hyper-
took place outside of the clinical encounter. One intervention
tension treatment (two studies), 30,31 cardiovascular risk (two
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TA B L E 1 Characteristics of included studies Study, year, country Design N = randomized Setting/recruitment
Baseline characteristics of participants:
Intervention(s) n = number randomized
Control n = number randomized
Watkins 1987 United Kingdom RCT N = 565 Primary care Patients dispensed antihypertensives by pharmacy OR Patients on GP hypertension disease register
Only whole sample data reported Age: “almost 2/3 were 55-6 4” % female: 59% Ethnicity: 27% non-C aucasian Hypertension status: “very similar with respect to diastolic blood pressure prior to the start of the study” Of 75% (313) having BP recorded in 6 mo prior to the study, 147 (47%) had DBP of at least 95 mmHg
n = 204 participants analysed; numbers randomized not reported by intervention group Information and medical record booklet: Mailed booklet with information on hypertension including treatment options, with the aim of providing an opportunity for the general practitioner and patient to set the objectives of management together and to share information on how well these had been obtained.
n = 210 participants analysed; numbers randomized not reported by intervention group control intervention not further specified
Montgomery 2003 Emmett 2005 (3-y follow-up) United Kingdom 2 × 2 factorial RCT (patients randomized) 4 groups*: 1. Decision analysis; 2. Decision analysis + video/leaflet; 3. Video/leaflet; 4. Usual care N = 217 Primary care Age 30-8 0 not currently taking antihypertensives, BP sustained at a level where GP would normally discuss initiation of pharmacological therapy.
Age (SD): Intervention: Decision analysis alone 59 (9), Decision analysis + video/ leaflet 57 (11) Control: Usual care 58 (11), Video/ leaflet 60 (10) % female: Intervention: Decision analysis alone 46% Decision analysis + video/ leaflet 49% Control: Usual care 49%, Video/leaflet 47% Ethnicity: not reported Hypertension status: Mean SBP/DBP in mmHg (SD) Intervention: Decision analysis alone 167 (11)/99 (6) Decision analysis + video/ leaflet 170 (14)/98 (8) Control: Usual care 169 (13)/100 (9) Video/leaflet 166 (14)/97 (8)
n = 103, of which: 52 received decision analysis alone, 51 received decision analysis + video/leaflet Decision analysis session (1 h with researcher), in which patient participant’s values regarding treatment outcomes are combined with individual cardiovascular risk information to create a decision tree to support decision making. Results of the decision analysis are presented as a paper summary Video/leaflet: Factual information including about BP, self-help measures and BP medication
n = 114, of which: 55 received video/leaflet in addition to usual care, and 59 received usual care Usual care—not further specified Video/leaflet: Factual information including about BP, self-help measures and BP medication
Deinzer 2009 Deinzer 2006 Germany Nonrandomized controlled N = 86 Primary care Patients: BP>/= 135/85 mmHg, excluding those with severe hypertension (BP >/= 160/100 mmHg), poor control, established cardiovascular disease or diabetes mellitus GPs (not characterized)
Intervention, control Age (SD): 60.9 (10.1), 61.1(9.3) Female (%): 67.5%, 65% Ethnicity: Not specified Hypertension status: Mean systolic blood pressure mmHg (SD): 145.4 (11.7), 144.9 (11.1) Mean diastolic blood pressure mmHg (SD): 86.6 (8.2), 86.1 (9.1)
n = 40 Training programme for GPs “to develop communication skills necessary to practice shared decision making” Regular supervision of trained physicians Regular consultations between trained physicians and patients to make decisions on further treatment (at 1, 3, 6 and 12 mo) Hypertension education module for patients
n = 46 Hypertension education module for patients
(Continues)
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TA B L E 1 (Continued) Study, year, country Design N = randomized Setting/recruitment Cooper 2011 Cooper 2009 (protocol paper) USA 2 × 2 factorial RCT N = 279 patients N = 50 physicians 4 groups: 1. Physician intensive intervention/ patient intensive intervention; 2. Physician minimal intervention/ patient intensive intervention; 3. Physician intensive intervention/ patient minimal intervention; 4. Physician and patient minimal intervention (serves as reference group for comparisons) Patients: Adults (18+ y) with hypertension Physicians: General internists/family physicians seeing patients in community-based primary care sites
Baseline characteristics of participants:
Intervention(s) n = number randomized
Control n = number randomized
Patient participants Physician intensive/patient intensive: Age (SD): 59.7 (11.9) Female (%): 65.1 Ethnicity (%): African American 62.6% Asian 2.4% American Indian 0% White 34.9% REALM >/= 9th Grade: 59.8% Physician minimal/patient minimal Age (SD): 62.4 (12.1) Female (%): 61.8 Ethnicity (%): African American 58.2% Asian 0% American Indian 1.8% White 40% REALM >/= 9th Grade: 70.9%
n (patients) = 224 Intervention groups: Physician intensive/patient intensive, n = 83 Physician minimal/patient intensive, n = 57 Physician intensive/patient minimal, n = 84 Patient intensive intervention: Previsit coaching, by community health workers (CHWs) to support patient participation. CHWs supported patients to identify changes they wanted to make to their interactions with their physicians, including practising asking questions and stating preferences. Stage 1: 20-min previsit coaching session prior to index visit with physician; 10-min debriefing after the visit. Stage 2: (i) 5 × 10-15-min phone calls over 12 mo; telephone support between these times (ii) Bimonthly photonovel depicting patients and physicians dealing with daily challenges of hypertension management (iii) Monthly newsletter including information about living with hypertension Physician intensive intervention: Communication skill training programme: Videotaped consultation between physician and simulated patient (African American hypertensive man) prior to the study randomization. Physician receives CD-ROM on which the videotaped consultation is recorded and coded (using Roter interaction analysis system), with individualized feedback on communication skills relevant to increasing patient engagement, activation, empowerment and adherence. Five specific behaviours targeted: 1. Elicit full spectrum of the patient concerns; 2. Probe pts hypertension knowledge and beliefs; 3. Monitor adherence and identify barriers; 4. Assess adherence-related lifestyle and psychosocial issues; 5. Elicit commitment to the therapeutic plan An accompanying workbook includes exercises for the physician to complete. Estimated time to complete workbook: 2 h Physicians receive a copy of the JNC-V II hypertension treatment guidelines at baseline and a monthly newsletter with study updates/recent evidence updates
n (patients) = 55 The “Physician minimal/patient minimal” serves as reference group with which changes in outcome are compared: Patient minimal intervention: Monthly newsletter including information about living with hypertension Physician minimal intervention: Videotaped consultation with a simulated patient (African American hypertensive man) prior to the study randomization; no feedback on the consultation is received Physicians receive a copy of the Joint National Committee 7th report hypertension treatment guidelines at baseline and a monthly newsletter with study updates/recent evidence updates
(Continues)
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JOHNSON et al.
TA B L E 1 (Continued) Study, year, country Design N = randomized Setting/recruitment
Baseline characteristics of participants:
Intervention(s) n = number randomized
Control n = number randomized
Tinsel 2013 Germany Tinsel 2012 (protocol paper) Germany Cluster RCT (randomization at practice level) Primary care N (GP practices) = 36 N (patients) = 1120 Practices: Located in south-west Germany; offering the full spectrum of family doctor’s health-c are services; not participating in another study of shared decision-making implementation Patients: Prescribed regular antihypertensive medications, who either have poorly controlled BP (24 h mean >130/80) or controlled BP with cardiovascular comorbidity
Intervention, control Age (SD): 63.8 (12.1), 65.0 (± 12.4) Female (%): 53.3%, 55.3% Ethnicity: Not reported Hypertension status: Mean SBP in mmHg (SD) 128.9 (12.5), 127.0 (11.8) Mean DBP in mmHg (SD) 79.2 (9.5), 76.8 (9.1)
17 GP practices n (patients) = 552 Training programme for GPs. Training was delivered over two or three sessions of 3 h each and included education about hypertension, principles of risk communication, implementation of shared decision making, use of motivational interviewing, the use of a decision aid listing options to lower cardiovascular risk and role-playing of case vignettes Cardiovascular risk table “including elements of shared decision making” Patient information flyers for GPs to distribute Six-monthly ambulatory blood pressure measurements and GP consultation at which blood pressure management was discussed and outcomes measured
19 GP practices n (patients) = 568 Usual care Six-monthly ambulatory blood pressure measurements and GP consultation at which blood pressure management was discussed and outcomes measured
Denig 2014 Denig 2012 (protocol paper) The Netherlands Cluster RCT with 2 × 2 factorial design with a control group (randomization at practice level (computer version or printed version), and subsequently at patient level [short version, extended version, or control]) General practice N (practices) = 18 N (patients) = 344 Practices: General practices in the north Netherlands Patients: Patients with diabetes under age 65 when diagnosed, excluding those with recent cardiovascular events Considered eligible for BP treatment intervention when SBP>= 140
Intervention, control Age (SD): 61.8 (8.5), 61.5 (8.5) Female (%): 42%, 26% Ethnicity: not reported Low educational attainment: 40%, 38% Hypertension status: Uncontrolled SBP >=140 mmHg (%) 50%, 42%
n (patients) = 225 Prior to the study, health-c are professional received training course in motivational interviewing and risk communication Decision aid for use before consultation (patient) and during consultation (with health-c are professional) including tailored information on risks and treatment options for multiple risk factors (Hba1c, SBP, LDL and smoking), focusing on shared goal setting and decision making Two forms of the decision aid were assessed using the factorial design: SHORT version presenting risk of myocardial infarction only, or EXTENDED version presenting additional outcomes
n (patients) = 119 Usual care Components of intervention: Prior to the study, health-c are professionals received training course in motivational interviewing and risk communication
BP, blood pressure; CHW, community health worker; DA, decision analysis; DBP, diastolic blood pressure; GP, general practitioner; Hba1c, glycated haemoglobin; JNC-VII, The Seventh Report of the Joint National Committee; LDL, low-density lipoprotein; RCT, randomized controlled trial; REALM, rapid estimate of adult literacy in medicine; SBP, systolic blood pressure; SD, standard deviation.
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JOHNSON et al.
Was the study free from selective outcome reporting?
H
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L
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H
L
L
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U
L
L
L
L
L
L
L
L
L
L
Deinzer (primary outcome not specified) i. BP ii. Hypertension knowledge iii. API iv. COMRADE
H
H
H
H
L
U
U
L
U
H
H
H
H
H
L
H
U
L
U
H
Cooper i.
L
L
U
L
H
U
H
H
U
H
L
L
U
L
H
H
H
H
U
H
L
L
U
L
H
L
L
H
U
H
L
L
L
L
L
H
L
L
L
U
L
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L
L
L
L
L
L
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U
Montgomery, Emmett i. DCS (primary outcome) ii. Adherence iii. iv.
BP Hypertension knowledge
ii.
Appointment keeping (primary outcome) SDM/adherence
iii.
BP
Tinsel i. ii. iii.
SDM Q-9 (co-primary endpoint) Adherence BP (co-primary endpoint)
iv.
Hypertension knowledge
Denig i.
Intensification of treatment
Overall assessment
Was the study adequately protected against contamination?
U
Was the study free from other risks of bias?
Was knowledge of allocated intervention adequately prevented during the study?
U
Were baseline characteristics similar?
U
BP (primary outcome) Hypertension knowledge
Were baseline outcome measurements similar?
U
Watkins i. ii.
Was the allocation adequately concealed?
U
Was the allocation sequence adequately generated?
Were incomplete outcome data adequately addressed?
8
F I G U R E 2 Risk of bias of primary studies. Effective Practice and Organisation of Care (EPOC) risk of bias assessment of included studies, by outcome grouping, for outcomes reported in at least three studies (Except Denig, where risk of bias is reported for the single outcome extracted for this review). BP, blood pressure; DCS, Decisional Conflict Scale; API, Autonomy Preference Index; SDM, shared decision making; SDM-Q -9, 9-item Shared Decision Making Questionnaire
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JOHNSON et al.
Intervention type
HCP training
Study
Outcomes assessed Communication outcomes
Clinical outcomes
Shared decision making
Blood
Clinician communi cation
Cardiovascular risk
pressure
Treatment intensification /chanage
Behavioural outcomes
Cognitive outcomes
Adherence
Hypertension knowledge
Smoking status
Healthcare use
Treatment intention
Other Patient reported Anxiety
HRQOL
Deinzer
Tinsel
HCP training /patient coaching
Cooper
Decision aid
Montgomery
Denig*
Patient leaflet
Watkins
F I G U R E 3 Outcomes reported in included studies, by intervention type and risk of bias. RED = high risk of bias; ORANGE = uncertain risk of bias; GREEN = low risk of bias; HCP = health-care professional. *Outcomes reported for the study by Denig are only those reported for the hypertensive subgroup within the study
studies), 31 diagnosis of diabetes, left ventricular hypertrophy
from 14 days to 18 months after the intervention. In studies in which
and lipid profile (all reported in a single study). 31 Behavioural
patients received an intervention, blinding patients to treatment al-
utcomes were medication adherence (three studies), 29,31,34
location was not possible. All studies measuring shared decision
and intention to start treatment
making in this review were assessed as uncertain27-29 or high risk
Anxiety was the only psychological outcome
of bias28,34 for this outcome, due to inadequate prevention of treat-
smoking status (one study) (one study).
31
reported (one study).
27
31
Cognitive outcomes were hyperten-
ment allocation knowledge. The SMD in change from baseline for
sion knowledge (four studies) 26-29 and intention to start treat-
shared decision-making measures, for studies with useable data at
ment (one study).
27
Only one study reported a measure of
health-c are use. 30 Other outcomes included health-r elated quality of life (one study)
28
and clinician communication
(one study). 33
12 months, is shown in Figure 3. Tinsel and colleagues29 use the nine-item Shared Decision Making Questionnaire (SDM-Q-9)37 as a coprimary outcome for the study. The mean SDM-Q -9 score decreased in both intervention and
Here, we discuss our primary outcome (shared decision making),
control groups. The difference, between intervention and control,
and the outcomes reported in at least three of the included studies
in mean change from baseline (to approximately 18 months) was
(blood pressure, hypertension knowledge and medication adher-
3.1182, 97.5% CI −2.3730; 8.6093, P = 0.2029.
ence). The decision to limit our discussion to the most commonly
Deinzer28 reported two shared decision-making measures: the
reported one was a post hoc decision, as detailed reporting of all of
Autonomy Preference Index (API)38 and a modified version of the
the outcomes reported was not practical. All outcomes are reported
COMRADE scale.39 In this study with a high risk of bias, the authors
in Table 2. None of the outcomes met our prespecified criteria for
report that at 1 year there was no change in API from baseline in
meta-analysis of at least three studies with comparable interven-
either the intervention or control group, although API scores were
tions and outcomes at low risk of bias; therefore, we did not pool
not reported (P = 0.83 for the comparison). A comparison between
data for any outcome.
the COMRADE scores in the intervention and control groups was not reported.
3.5.1 | Primary outcome: shared decision making— risk of bias (Figure 2) and results (Table 2 and Figure 4) The four studies measuring shared decision making
27-29
The primary outcome in the study by Montgomery and colleagues27 was the Decisional Conflict Scale (DCS), a 16-item patient self-report scale.40 The DCS was measured after receipt of the inter-
used differ-
vention (mean 14 days after randomization). The adjusted difference
ent patient self-report measures; measures are described in Table 2.
in mean DCS score (decision analysis vs no decision analysis) was −9.4
Shared decision making was assessed at different times, ranging
(95% CI −13.0 to −5.8), P
